The US Food and Drug Administration (FDA) has accepted Tyme Technologies’ investigational new drug (IND) application for its drug candidate, SM-88, for treatment of breast cancer.
According to the company, SM-88 is believed to be a first-in-class metabolic inhibitor targeting cancer cells intended to result in decreased mucin defence to reactive oxygen.
With this FDA acceptance, the company intends to start patient enrolment into the study.
SM-88 is believed to be a first-in-class drug that harnesses the body’s own immune defences to fight tumour cells.
Tyme president and chief executive officer Steve Hoffman said: "FDA acceptance of this IND is a major milestone for Tyme in our efforts to provide a new class of tools in the fight against cancer.
"We were delighted to receive the FDA response to our extensive preclinical data package, as well as the approval of our trial design.
"Our focus now is on preparing to enrol the first patients in the study. In addition to studying SM-88 in breast cancer patients, we are also contemplating, with guidance from our Scientific and Medical Advisory Board, expanding our programme to include multiple arms focused on differentiated types of cancer."
Earlier, the company had completed a proof-of-concept clinical study for SM-88 in late-stage cancer patients with relapsed or highly refractory disease.
Currently, the company is developing SM-88, a proprietary compound, for use in humans.
SM-88 is a new combination drug that synergistically targets the unique metabolic features of cancer cells, providing a selective method of altering the susceptibility of cancer cells to oxidative stress.
The company is focused on discovering and developing highly targeted cancer therapeutics for a broad range of oncology indications.